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Session 8, Tracks C: Exploring Different Pharmacovigilance Methods to Strengthen Post-Market Monitoring
Session Chair(s)
Bianca Passos, MBA, RPh
Country Safety Head - Brazil
Sanofi, Brazil
Rosana Mastellaro, PharmD, RPh
Director Technical Regulatory and Inovation
SINDUSFARMA, Brazil
This session will analyze the importance of safety surveillance to enhance safety signal detection and monitor the effectiveness of risk minimization strategies, in a growing data volume context. Attendees will also explore the adoption of different pharmacovigilance (PV) methods according to the risk to be evaluated, types of products, and available sources.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize methods used by health programs to monitor the safety of incorporated products
- Discuss the value of different sources of PV data for signal detection and effectiveness measures of risk minimization strategies
- Identify the changes the pandemic has brought concerning sources of data and methods to analyze it
Speaker(s)
ConcePTION: The Use of Multiple Healthcare Databases in Europe for Medication Safety Monitoring in Pregnant Women: Leonardo R. Pereira, PharmD, MSc
Clinical Safety Director
Roche, United Kingdom
Can Electronic Health Records Databases Complement Spontaneous Reporting System Databases in Post-Marketing Monitoring?: Vaishali Patadia, PhD
Executive Director, Signal Mgt and Risk Mgt
Amgen, United States
Strengthening Pharmacovigilance and Adherence to the Malaria Treatment in Brazil: Sheila Rodrigues Rodovalho, PhD, MSc
Technical Officer
Pan American Health Organization, Brazil
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